This week, the Food and Drug Administration finally approved for marketing the latest statin drug, rosuvastatin (Crestor, by AstraZeneca Pharmaceuticals). Rosuvastatin is one of the new statins that were nicknamed "superstatins" a few years ago, because they appeared to reduce LDL cholesterol to a greater degree than previously available statin drugs. Last month, for instance, rosuvastatin was reported to reduce LDL cholesterol by 43% with the 5 mg dose, and by 62% with the 40 mg dose. This degree of cholesterol lowering is greater than is typically reported with statins.
However, the approval of rosuvastatin is somewhat controversial. The controversy exists for two reasons.
First, another remarkably effective statin - cerivastatin (Baycol), by Bayer, which, by the way, we no longer refer to as a superstatin because of its unfortunate history - was removed from the market in 2001 because of reports of a fatal muscle disorder (rhabdomyolysis) caused by the drug. Rosuvastatin was submitted to the FDA at about the time cerivastatin was being pulled from the market. Understandably, the FDA (which was criticized for allowing cerivastatin to get to market) has since been exceedingly cautious in approving another "remarkably effective" statin. (Read more about the Baycol story here.) In this case, the FDA took over 2 years in its deliberations.
Second, side effects were reported with rosuvastatin that appeared reminiscent of the Baycol experience. Cases of rhabdomyolysis were seen with this new statin as well, though only with the 80 mg dose (the highest approved dose is 40 mg.) Further, cases of kidney abnormalities of uncertain significance were also seen with the 80 mg dose (but not with lower dosages.)
After reviewing all the data, the FDA concluded that the drug could be released to market in the 5, 10 and 40 mg doses, but not the 80 mg dose.
Should you ask for rosuvastatin?
In DrRich's opinion, not at this time. The true incidence of side effects with this drug - as with any new drug - may not become apparent until it has been in widespread use for some time. Given the problems seen with Baycol after its market release, and given that several other effective statins are readily available, there would seem to be little need to rush to your doctor's office demanding this new stuff. (There are plenty of other statins available.)On the other hand, for patients whose cholesterol levels remain too high after trials with other statins, it might be entirely reasonable to try rosuvastatin. If you are placed on this drug, your doctor ought to consider testing your urine periodically for signs of the still-mysterious kidney disorder seen in a few patients taking high doses of rosuvastatin (in these patients, blood and/or protein was seen in the urine,) in addition to the liver function tests that should be measured periodically in any patient receiving any statin.
